Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
FDA adverse event reports and recall history for monitor, physiological, patient (without arrhythmia detection or alarms) (product code MWI), from the public MAUDE corpus and the live FDA recall database.
- Total reports
- 2,174
- Deaths
- 46
- Injuries
- 118
- Malfunctions
- 1,986
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused twice in 2026 during FDA reporting-system changes and has since resumed.
Recent recalls
- 2026-09-18Open, ClassifiedProcess change control
Midmark IQvitals Zone, automatically and noninvasively measures systolic and diastolic blood pressure, pulse rate, temperature (temporal), and oxygen saturation (SpO2) for adult and pediatric patients, Model Number: 1-200-0320 with Kit Number: 4-000-0622
A performance issue may result in inaccurate blood pressure readings when the Linear Deflation Method is used.
- 2026-09-18Open, ClassifiedProcess change control
Midmark IQvitals Zone, automatically and noninvasively measures systolic and diastolic blood pressure, pulse rate, temperature (temporal), and oxygen saturation (SpO2) for adult and pediatric patients, Model Number: 1-200-03300 with Kit Number: 4-000-0624
A performance issue may result in inaccurate blood pressure readings when the Linear Deflation Method is used.
- 2026-09-18Open, ClassifiedProcess change control
Midmark IQvitals Zone, automatically and noninvasively measures systolic and diastolic blood pressure, pulse rate, temperature (temporal), and oxygen saturation (SpO2) for adult and pediatric patients, Model Number: 1-200-0350 with Kit Number: 4-000-0722
A performance issue may result in inaccurate blood pressure readings when the Linear Deflation Method is used.
- 2026-09-18Open, ClassifiedProcess change control
Midmark IQvitals Zone, automatically and noninvasively measures systolic and diastolic blood pressure, pulse rate, temperature (temporal), and oxygen saturation (SpO2) for adult and pediatric patients, Model Number: 1-200-0360 with Kit Number: 4-000-0724
A performance issue may result in inaccurate blood pressure readings when the Linear Deflation Method is used.
- 2026-08-27Open, ClassifiedDevice Design
PORTRAIT CORE SERVICES SOFTWARE V1.1, Ref# 5700209
Software issue may result in a loss of patient monitoring at the Hub and Central Viewer. In addition, all alarm settings could be reset to factory defaults following the update and will not follow the alarm settings previously configured for each patient or care area.
- 2026-08-27Open, ClassifiedDevice Design
PORTRAIT COMPUTE AND CORE SERVICES V1.2, Ref# 5700592
Software issue may result in a loss of patient monitoring at the Hub and Central Viewer. In addition, all alarm settings could be reset to factory defaults following the update and will not follow the alarm settings previously configured for each patient or care area.
- 2026-08-27Open, ClassifiedDevice Design
PORTRAIT CORE SERVICES SOFTWARE V1.0.5, Ref# 5697353
Software issue may result in a loss of patient monitoring at the Hub and Central Viewer. In addition, all alarm settings could be reset to factory defaults following the update and will not follow the alarm settings previously configured for each patient or care area.
- 2026-08-27Open, ClassifiedDevice Design
FRU (Field replaceable unit), PORTRAIT CORE SERVICES SW RELOAD V1.1, Ref# 5700225
Software issue may result in a loss of patient monitoring at the Hub and Central Viewer. In addition, all alarm settings could be reset to factory defaults following the update and will not follow the alarm settings previously configured for each patient or care area.
- 2026-08-04Open, ClassifiedSoftware design
GE Healthcare Portrait Core Services SW V 1.2.0, REF 5700592
Portrait Core Services Software version V1.2.0 Security Vulnerability
- 2026-03-11Open, ClassifiedUnder Investigation by firm
HealthCast "Vital Sync" Remote Patient Monitoring System which consists of: Product Number: VSLBASE03P / VITALSYNCSW03 Model / UDI-DI codes: Vital Sync 3.3.1 / 10884521844933 Vital Sync 3.4.0 / 10884521844940 Vital Sync 3.4.1 / 10884521847569 (OUS Only) Vital Sync 3.4.2 / 10884521856127 Product Number: VSLBASE04P / VITALSYNCSW04 Model / UDI-DI codes: Vital Sync 4.0.0 / 10884521849358 Vital Sync 4.0.2 / 10884521856134 The Vital Sync" Informatics Manager is software that is intended to route and store medical device data and device diagnostic information from supported devices to the Virtual Patient Monitoring Platform, 3rd Party Annunciation Systems, Electronic Medical Record (EMR) and Clinical Information System (CIS).
Due to complaints and investigations stating that alarms from the primary patient bedside monitor was not alarming/being transmitted and received on the remote patient monitoring system.
Monitor monitor, physiological, patient (without arrhythmia detection or alarms) automatically
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